K852054 is an FDA 510(k) clearance for the CONTACT LENS LOUPE, INSPETION LOUPE. This device is classified as a Gauge, Lens, Ophthalmic (Class I - General Controls, product code HLN).
Submitted by Ascon Medical Instruments, Ltd. (Westmont, US). The FDA issued a Cleared decision on September 5, 1985, 119 days after receiving the submission on May 9, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1420.
| 510(k) Number | K852054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1985 |
| Decision Date | September 05, 1985 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HLN — Gauge, Lens, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1420 |